An Ultra-Brief ICBT Intervention: The 'Things You Do' Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina
About this trial
Research shows that the single lesson 'Things You Do' Intervention is effective in increasing engagement in everyday healthy actions. However, no research has examined whether its effectiveness is enhanced by incorporating personalized feedback on participants' current level of engagement in healthy actions. In this randomized controlled trial, clients will be randomly assigned to either receive or not receive personalized feedback informing them of their level of engagement in healthy actions over the previous week and encouraging them to participate in more healthy activities. The investigators will examine whether this feedback increases engagement in healthy actions and enhances the effectiveness of the 'Things You Do' Intervention as assessed through changes in primary outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Canadian resident;
Aged 18 years or older;
Access to a computer (or another appropriate device) and the Internet;
Willingness to learn information and skills to self-manage mental health difficulties.
Disqualifiers
Unable to read and understand English (All content is provided in English ).
Trial design
Design model
Parallel
Treatments tested in this trial
Things You Do Program (Ultra-Brief ICBT)
BehavioralThe TYD program is an ultra-brief ICBT intervention developed at Macquarie University, Australia. The intervention provides psychoeducation on mental health and five areas of healthy actions, known as the "Things You Do," along with practical skills to support engagement in these actions. These five areas include Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson, a Weekly Planner, an Activity Guide, and a daily 'Tip of the Day' Offered for 30 days. The lesson content is presented across 25 slides using text and infographics and requires approximately 30-60 minutes to review. A key component of the TYD intervention is the daily 'Tip of the Day.' These are daily messages that clients receive for 30 days following the start of the intervention. Each message provides a tip or suggests a healthy action that clients can engage in that day. Clients complete the program without therapist support.
Things You Do Program Plus Personalized Feedback
BehavioralParticipants in this arm receive the same Things You Do (TYD) intervention as those in the comparative arm, with the addition of personalized feedback report. The TYD program is an ultra-brief ICBT intervention providing psychoeducation on mental health and five areas of healthy actions: Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson (25 slides), Weekly Planner, Activity Guide, and daily "Tip of the Day" delivered for 30 days following enrollment in the intervention. Participants complete the intervention independently without therapist support. In addition to the standard TYD intervention, participants in this arm receive a personalized feedback report at screening, in Week 3, and in Week 5 following enrollment. Reports provide individualized feedback on participants' engagement across the five areas of healthy actions and are intended to encourage and motivate engagement in these areas.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: ICBT Without Personalized FeedbackActive comparator 1 intervention
Group B: ICBT With Personalized FeedbackExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Things You Do-15 (TYD-15)
A measure of engagement in healthy actions over the previous week. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Routine, Thoughts, Social, Activity, and Goals. Scores are summed into subscale scores ranging from 0 to 12, with a total score ranging from 0 to 60. Higher scores on this measure indicate greater engagement in healthy actions.
Time frame
Baseline (intake), week 3 and 52
Patient Health Questionnaire-9 (PHQ-9)
Track the change in depression symptoms over a two-week period. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores indicate greater severity in depression symptoms.
Time frame
Baseline (intake), weeks 3 and 53
Generalized Anxiety Disorder - 7 (GAD-7)
Track the change in anxiety symptoms over a two-week period. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21. Higher scores indicate greater severity in self-reported anxiety symptoms.
Time frame
Baseline (intake), weeks 3 and 5Secondary outcomes
1
Satisfaction with Life Scale (SWLS)
A measure of satisfaction with one's life. 5 items are measured on a 7-point scale ranging from 1-7. Scores are summed to produce a total ranging from 5 to 35 with higher scores indicating greater satisfaction with one's life.
Time frame
Baseline (intake), week 3 and 52
Feedback Questionnaire
A bespoke questionnaire consisting of 10 items with varying response formats measuring perceived treatment change and gathering feedback on likes and dislikes with the course. Items are not designed to be combined into a unitary measure. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Time frame
Week 3 and 53
Personalized Feedback Report Satisfaction Questionnaire
A bespoke 4-item questionnaire presented to clients randomized to the Feedback Group. The questionnaire uses a combination of various formats to assess clients' perception of the personalized feedback reports they received and their effectiveness. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Time frame
Week 3 and 5Sponsors and contacts
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University of Regina
Lead sponsor
Macquarie University, Australia
Collaborator
Source ClinicalTrials.gov